Status:
UNKNOWN
Omega 3, Leucine, Probiotic Lactobacillus Paracasei PS23 on Muscle Mass in Sarcopenic Subjects
Lead Sponsor:
Azienda di Servizi alla Persona di Pavia
Collaborating Sponsors:
Abiogen Pharma
Conditions:
Sarcopenia
Elderly
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate the effect of supplementation with a nutritional blend based on Omega 3 fatty acids, the probiotic leucine Lactobacillus paracasei PS23 (OLEP), on muscle mass r...
Eligibility Criteria
Inclusion
- Sarcopenic patients (diagnosis made according to the criteria Revised European Consensus on Definition and Diagnosis)
- Body Mass Index between 20 and 30 Kg/m2
Exclusion
- severe renal failure (glomerular filtration rate \< 30 mL/min)
- moderate to severe liver failure (Child-Pugh class B or C)
- endocrine diseases associated with calcium metabolism disorders (except osteoporosis)
- known psychiatric disorders
- cancer (over the past 5 years)
- hypersensitivity to any component of the investigational nutritional supplement and
- taking to protein/amino acid supplements (up to 3 months before starting the study)
- patients unable to take oral therapy
- receiving or with indication for artificial nutrition
- who had been included in another clinical nutrition trial
Key Trial Info
Start Date :
January 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04702087
Start Date
January 22 2021
End Date
December 1 2022
Last Update
October 5 2021
Active Locations (1)
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1
Azienda di Servizi alla Persona
Pavia, Italy, 27100